Kornimate/medical-research-clean huggingface dataset:
a study of ly2484595 in patients with high ldl-c or low hdl-c

Conditions: Dyslipidemia

Summary: the primary purpose of your participation in this study is to help answer the following research question(s) * whether ly2484595 in combination with a statin drug (atorvastatin, simvastatin or rosuvastatin; currently used to treat abnormal fat or cholesterol in blood) improves the blood fat profile more than statins alone. * whether ly2484595 alone improves blood fats profile compared to sugar pills. * whether ly2484595 interferes with break down or functioning of statins. * whether ly2484595 has any side effects that would not support testing it in future studies.

patients will be stratified according to baseline levels of serum triglycerides (\<150 or greater than or equal to 150 milligram/deciliter (mg/dl), hdl-c (\<45 or greater than or equal to 45 mg/dl for men; \<50 or greater than or equal to 50 mg/dl for women), and region (united states or europe). after a diet lead-in and prior therapy washout phase, subjects meeting all entry criteria will be randomized to one of 10 double-blind treatment groups for a 12 week treatment phase. after randomization, patients will self-administer the study drugs once a day with a low fat meal as their first meal of the day.

Eligibility criteria:
inclusion criteria: • diagnosed with low high density lipoprotein cholesterol (hdl-c) or hypercholesterolemia, after diet lead-in/washout of lipid therapies exclusion criteria: * history of coronary heart disease, or hardening of the arteries, or heart does not pump sufficiently well * hypertension or high blood pressure that is not under control or your study physician does not consider the electrical activity of heart (electrocardiogram \[ecg\]) to be compatible with participation in the study * history of a bad skin rash, a prior rash due to a drug or a history of chronic skin disorder (such as psoriasis or eczema) * intolerance to certain lipid modifying drugs (including statins and cholesteryl ester transfer protein (cetp) inhibitors) * not willing to stop taking prescription or over the counter drugs you use to control fats in your blood (like fish oil, niacin or statin) or pills to decrease your weight, including herbs * not willing to follow the diet (low-fat) that the study physician will recommend * have disease of liver, kidneys, muscles or other organs of body, a serious infection or cancer, or abnormal laboratory tests that study physician does not consider compatible with participation in the study * breastfeeding woman or a woman who can still become pregnant, but are not willing to use a valid birth control measure to prevent pregnancies

Keywords: dyslipidemias mixed dyslipidemia hypercholesterolemia atherosclerosis atorvastatin simvastatin rosuvastatin metabolic diseases antilipemic agents enzyme inhibitors anticholesteremic agents cholesteryl ester transfer protein inhibitors cholesteryl ester lipid metabolism disorders
safety and performance of 032-11 haemostat in cardiac and thoracic aortic surgery

Conditions: C.Surgical Procedure; Cardiac; Haemorrhage.

Summary: the effectiveness objective of this study is to evaluate whether 032-11 is non-inferior to floseal as an adjunct to achieving haemostasis during surgical procedures involving cardiac and aortic thoracic surgery.


Eligibility criteria:
inclusion criteria: * the patient must be equal or greater than 18 years old * the patient must have elective or non-elective urgent cardiac surgery or thoracic aortic surgery * the patient must have no childbearing potential or have a negative serum or urine pregnancy test within 7 days of the planned surgery or in the opinion of the investigator performs adequate contraception * the patient is willing and able to be contacted for the follow-up visit at 6- 8 weeks * the patient must provide written informed consent using a form that is reviewed and approved by the iec exclusion criteria: * the patient is currently enrolled in this or another investigational device or drug trial that has not completed the required follow up period. * the patient has a known hypersensitivity to materials of bovine origin * the patient does not wish to receive materials of bovine or shellfish origin for any reason
assessment of motor adaptation in precision grip performance of children

Conditions: Hand Strength, Child, Sensation, White Matter

Summary: preterm children usually suffer from mild hand motor performance, however, the problem are rarely detected in time. identifying the pathology causing deficits in sensorimotor control of a hand helps the occupational therapist to determine appropriate clinical decision-making for intervention. well-motor performance requires complete sensorimotor control. understanding hand sensorimotor control mechanism and its neural control can help clinicians find the reason behind hand motor deficits. the analysis of motion adaptation of the precision pinch behavior in the perturbing environment has been regarded as a clinically meaningful tool for evaluating sensorimotor control of a hand, especially for the complex anatomical structure of bone and tendon. the motor adaptation analysis for the precision grip behavior can provide the temporal and spatial parameters of dynamic grip force adjustment. therefore, the exploration of motor adjustment can provide in-depth understanding of the neural mechanisms that lead to impairment of motor function and skill acquisition of a child, which can assist clinical occupational therapist in identifying the cause and severity of impairment of children's hand skills and provide appropriate strategies and types of treatment. the recent research on children's motor adaptation focuses on the discussion of the efficiency of motor adaptation in unfamiliar or disturbing task situations. thus, the first purpose of this research is to develop an easy-to-detect apparatus to detect the adjustment efficiency of a responsive grip behavior of children in a disturbing pinch-lifting task and to construct the reliability of its evaluation. the second purpose of the research is to understand the correlation between the efficiency of children's reactive pinch performance adjustment and the results of traditional evaluation of fine motor development scale and sensorimotor control assessments. the third purpose of the research is to analyze the difference in motor adjustment of a precision pinch performance at different ages of preschool children. the fourth purpose is to compare the efficiency of motor adaptation in preterm and term children. in addition, preterm birth is often accompanied by white matter abnormalities and affects future hand motor performance. investigating white matter imaging markers for predicting motor adaptation can help early detection of problems. therefore, the fifth objective was to explore whether specific white matter imaging markers can predict the efficiency of reactive motor adaptation.


Eligibility criteria:
inclusion criteria: 1. must be able to do reach-to-grasp performance 2. intact comprehension ability exclusion criteria: 1. diagnosis of cerebral palsy and other genetic or congenital damage 2. bone and nerve damage in the upper limbs in the past year 3. un-correctable problems of vision or hearing impairment

Keywords: hand strength, child, sensation, white matter
a safety and dose finding study of plasmin (human) administered into the middle cerebral artery of stroke patients

Conditions: Acute Ischemic Stroke

Summary: this study tests the drug, plasmin (human), in patients with a stroke due to a clot in the middle cerebral artery (mca). plasmin is an enzyme that causes clot lysis by cleaving a clot component, fibrin. in this study, plasmin (human) is administered locally through a catheter to the clot within 9 hours of the stroke onset. three doses of plasmin (human) (20 mg, 40 mg, and 80 mg) are being tested in 3 different groups of patients. patients are monitored by imaging of the affected artery and functional testing.

this is a phase 1/2a, open-label, multi-center, sequential dose escalation, safety study of plasmin (human) in acute ischemic stroke caused by middle cerebral artery occlusion documented by arteriography. plasmin (human) will be administered through a catheter into the thrombus within 9 hours of stroke onset. approximately sixty-one (61) patients will be enrolled and will receive plasmin (human). the objectives of this study are to determine the safety of escalating doses of plasmin (human) and to determine the proportion of patients with treatment success, defined as partial or full recanalization.

Eligibility criteria:
inclusion criteria: 1. 18 to 85 years of age 2. male or female 3. new focal, potentially disabling neurologic deficit clinically localized to the mca distribution 4. intra-arterial therapy with plasmin completed within 9 hours of stroke onset 5. a national institutes of health stroke scale score ≥ 4 and ≤ 25 exclusion criteria: 1. intracranial procedures or intracranial or systemic bleeding within the last year 2. intracranial neoplasm (except meningioma), septic embolism, or unsecured aneurysm 3. active bleeding 4. history of stroke in previous 6 weeks 5. uncontrolled hypertension 6. renal disease or renal dialysis 7. treatment with any plasminogen activator within the last 48 hrs. 8. therapy with a glycoprotein iib/iiia inhibitor in 5 days prior to study enrollment or at any time during study

Keywords: stroke plasmin thrombus ischemic middle cerebral artery thrombolysis intra-arterial fibrin
protection from acute kidney injury (aki) with basis™ treatment

Conditions: AKI

Summary: this study is a single-center, prospective, randomized, double-blinded, placebo-controlled phase ii clinical trial to evaluate the efficacy of "nad+ supplementation" with basis™ (nicotinamide riboside and pterostilbene) in preventing acute kidney injury (aki) in patients undergoing complex aortic aneurysm repair and open aortic arch reconstruction.


Eligibility criteria:
inclusion criteria: * a patient may be included in the study if the following conditions are present: 1. male or female; 2. age \> 18 years old; 3. patients who match the criteria for indication of elective open aortic arch replacement or repair: 1. total arch; 2. non-total arch; 4. patients who match the criteria for indication of elective complex aortic aneurysm repair has to respect the following conditions: a. patients undergoing complex aortic aneurysm open reconstruction with a suprarenal clamp; i. thoracoabdominal aortic aneurysms crawford extent i to iv ; ii. abdominal aortic aneurysms of juxtarenal, pararenal, or paravisceral type; b. for endovascular approach: i. patients with pararenal or thoracoabdominal aortic aneurysms crawford extent i to iv and known stage iii or iv of chronic kidney disease (ckd); ii. patients with pararenal or thoracoabdominal aortic aneurysms crawford extent i to iv and solitary or single functioning kidney and known stage iii or iv ckd; 5. patients will be allowed to participate in concomitant endovascular aortic stent-graft trials and prospective cohort studies as long as these do not involve another investigational study drug. exclusion criteria: * patients must be excluded from the study if any of the following conditions are true: 5.2.1 general exclusion criteria 1. unwilling to comply with the follow-up schedule; 2. inability or refusal to give informed consent by the patient or a legally authorized representative; 3. pregnant or breastfeeding; 4. subject who takes multivitamins containing vitamin b3 derivatives in a dose \> 200 mg/day; 5.2.2 clinical / laboratory exclusion criteria 5. renal failure defined as egfr\< 15 ml/min/1.73m2 6. patients in permanent renal replacement therapy; 7. patients with chronic liver disease: child-pugh score class b and c; 5.2.3 medication exclusion criteria 8. patients in chemotherapy scheme; 9. patients taking any immunosuppressant, except for corticosteroids; 10. patients taking any of these well-known p-glycoprotein substrates: digoxin, fexofenadine, indinavir, sirolimus.

Keywords: aki open vascular surgery endovascular surgery aortic arch reconstruction acute kidney injury
diagnostic validation of rapid detection of the covid-19 causative virus (sars-cov-2) in saliva samples by mass spectrometry

Conditions: Covid19

Summary: in order to control the covid-19 pandemic, a policy for the diagnosis and screening of people likely to be infected with sars-cov-2 has been established the reference diagnostic test is rt-pcr on nasopharyngeal swab. nasopharyngeal swabbing requires training, generates a risk of aerosolization and therefore viral transmission to the operator, and is unpleasant or even painful for the patient. rt-pcr is efficient, but time-consuming. it is therefore necessary to consider techniques that are less subject to difficulties of production and sampling, and less time-consuming. tandem mass spectrometry on saliva samples is a promising option. a combined "mass spectrometry/saliva test" should provide faster results.


Eligibility criteria:
inclusion criteria: * the patient must not have opposed their inclusion in the study * patient presenting to the walk-in center for emerging biological risks for sars-cov-2 screening by nasopharyngeal swab or hospitalized in the infectious and tropical diseases department for severe sars-cov-2 infection, diagnosed by rt-pcr on nasopharyngeal sample, taken at nîmes university hospital, in the previous 24 hours. exclusion criteria: * patient already included in the study * the subject is in a period of exclusion determined by a previous study * it is impossible to give the subject clear information * the patient is under safeguard of justice or state guardianship * patient unable to give consent
safety study of adjuvant docetaxel-carboplatin treatment for resected lung cancer

Conditions: Non-small Cell Lung Cancer

Summary: the purpose of this study is to determine whether it is safe to treat lung cancer patients who have undergone an attempt at curative resection with the combination of docetaxel and carboplatin.

patients with stage ib - iiia nsclc participated in an open-label, single arm study to assess the safety and tolerability of docetaxel (75 mg/kg) and carboplatin (auc 5.5) administered for 3 cycles after resection for curative intent. the primary endpoint of the study was safety, as reflected by a febrile neutropenia rate of \<10%. other endpoints assessed protocol compliance and the impact of minimally invasive surgical technique.

Eligibility criteria:
inclusion criteria: * non-small cell lung cancer stage ib - iiia, complete resection with mediastinal lymph node dissection * ecog status 0-1 * \>14 and \<56 days since resection exclusion criteria: * prior chemotherapy and/or radiation therapy for lung cancer * peripheral neuropathy \> grade 1 * concurrent other malignancies, other than basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix * medical condition that will not permit treatment or follow up according to the protocol * prior treatment with docetaxel or carboplatin * hypersensitivity to polysorbate 80, platinum-containing compounds or mannitol * treatment with other investigational anti-cancer drugs within 30 days of registration * pregnant or nursing women * hiv-positive patients

Keywords: lung cancer adjuvant therapy
mr(magnetic resonance) imaging of neurotransmitters in chronic pain

Conditions: Chronic Low Back Pain; Diabetic Peripheral Neuropathy; Knee Osteoarthritis

Summary: this study is designed to assess: hypothesis #1: that there is a significant central pain component in a distinct subset of patients diagnosed with knee osteoarthritis(koa), chronic low back pain(clbp), painful diabetic neuropathy(pdn.) hypothesis # 2: to establish a reliable strategy for differentiation of central pain predominant from peripheral pain predominant knee osteoarthritis(koa), chronic low back pain(clbp)and peripheral diabetic neuropathy(pdn) patients using clinical features, experimental pain testing and magnetic resonance(mr) spectroscopy.

this study will identify clinical and neuroimaging markers in chronic pain in an effort to provide individual-based treatments. this study will differentiate chronic pain subjects (knee osteoarthritis, low back pain and painful diabetic neuropathy) into two groups: those who have central pain predominant symptoms and those who have peripheral pain predominant symptoms. the response to medical treatment between these two groups is quite different, thus a reliable strategy to correctly categorize chronic pain sufferers offers the opportunity to provide targeted, effective treatments. chronic pain is a prevalent problem in the va veteran population with significant associated costs; in particular knee osteoarthritis, chronic low back pain and painful diabetic neuropathy are common in this population. the proposed study will use different clinical pain tests and advanced neuroimaging techniques to improve our understanding of chronic pain and improve patient outcomes.

Eligibility criteria:
inclusion criteria: - must be right handed. (chronic pain with knee osteoarthritis) * diagnosed with: unilateral, symptomatic knee osteoarthritis based on american college of rheumatology (acr) criteria. * have had a knee x-ray within the last 6 months. * must have average pain intensity of 4 or greater on a 0 (no pain) to 10 (worst pain imaginable) scale. (chronic low back pain) * have primary complaint of constant or intermittent back pain of at least 6 months duration. * have a roland morris disability questionnaire score of \>7. (diabetes mellitus with painful peripheral neuropathy) * have a diagnosis of diabetes mellitus for at least 6 months. * have a diagnosis of diabetic peripheral neuropathy. * have had electromyography(emg) testing within the last 6 months. * have a \>40 mm score on the short-form mcgill pain questionnaire. (healthy controls) * must be pain free * no history of neurological or psychiatric illness. * no diagnosis of diabetes mellitus. * no evidence of neuropathy on clinical assessment. exclusion criteria: * being pregnant. * have metal in the body or other contraindications to magnetic resonance imaging (mri). * have a chronic pain condition unrelated to knee osteoarthritis, chronic low back pain or diabetes. * have currently or a history of brain infection, stroke or tumor. * have a risk factor for other non-diabetic neuropathies
phase 3 efficacy and safety study of cd07805/47 topical gel in subjects with facial erythema of rosacea

Conditions: Rosacea

Summary: phase 3 efficacy and safety study of cd07805/47 topical gel in subjects with facial erythema associated with rosacea. the study hypothesis is that cd07805/47 gel, applied topically once daily is more efficacious than vehicle and provides an acceptable safety profile in the treatment of facial erythema associated with rosacea


Eligibility criteria:
key inclusion criteria: 1. male or female who is at least 18 years of age or older. 2. a clinical diagnosis of facial rosacea. 3. a clinician erythema assessment (cea) score of greater than or equal to 3 at screening and at baseline/day 1 (prior to the study drug application). 4. a patient self assessment (psa) score of greater than or equal to 3 at screening and at baseline/day 1 (prior to the study drug application). key exclusion criteria: 1. more than 20 facial inflammatory lesions of rosacea 2. particular forms of rosacea (rosacea conglobata, rosacea fulminans, isolated rhinophyma, isolated pustulosis of the chin) or other concomitant facial dermatoses that are similar to rosacea such as peri-oral dermatitis, demodicidosis, facial keratosis pilaris, seborrheic dermatitis, acute lupus erythematosus, or actinic telangiectasia. 3. current treatment with monoamine oxidase (mao) inhibitors, barbiturates, opiates, sedatives, systemic anesthetics, or alpha agonists. 4. less than 3 months stable dose treatment with tricyclic anti depressants, cardiac glycosides, beta blockers or other antihypertensive agents. 5. current diagnosis of raynaud's syndrome, thromboangiitis obliterans, orthostatic hypotension, severe cardiovascular disease, cerebral or coronary insufficiency, renal or hepatic impairment, scleroderma, sjögren's syndrome, or depression.
study on neutropenia induced by adjuvant paclitaxel/carboplatin chemotherapy in patients with epithelial ovarian cancer

Conditions: Epithelial Ovarian Cancer

Summary: to develop a robust prediction model to predict the occurrence of grade 3-4 neutropenia induced by adjuvant paclitaxel/carboplatin chemotherapy in patients with epithelial ovarian cancer and to validate this model.


Eligibility criteria:
inclusion criteria: * patients with figo stage i-iv epithelial ovarian cancer after staging or debulking surgery * patients who is planned to receive (prospective cohort) ro who received (retrospective cohort) adjuvant chemotherapy with paclitaxel and carboplatin * patients who have signed approved informed consent exclusion criteria: * uncontrolled medical disease * active infectious disease * previous pelvic radiation therapy * previous chemotherapy (prospective cohort) * patients with disease which can cause neutropenia * patients who will receive other targeted therapy or immunotherapy during adjuvant therapy (prospective cohort). * pregnant or lactating woman

Keywords: neutropenia paclitaxel carboplatin epithelial ovarian cancer
identification of biomarkers in ischemic stroke - clinical trial

Conditions: Stroke, Ischemic; Stroke Hemorrhagic

Summary: the objective of the study is to determine rna blood biomarker based on 9 genes already identified in experimental studies, whose expression would be significantly increased in patient with ischemic stroke compared to controls.

this is a monocentric study. it's a case-control study with case being first-ever ischemic stroke and controls being healthy (stroke free) subject patients paired for age, sex and cardiovascular risk or hemorrhagic stroke paired for age and sex. patients are followed for one year. blood samples will be taken at inclusion, 12h, 24h, 48h, 7d, 3m and 1y. microvesicles samples will be taken at inclusion, 7d and 3m.

Eligibility criteria:
inclusion criteria: * for ischemic stroke : * age \> 18-year-old * ischemic stroke diagnosed on clinical presentation and cerebral imaging (ct or mri imaging) * inclusion inferior to 6 hours from stroke onset * initial nihss score \> 0 at the time of clinical examination * patients with multimodal imaging either through mri or ct perfusion and supra-aortic vessels and intra-cerebral vessels (willis circle) imaging \<0 * procedure of signed consent in situation of emergency : consent of the patient if he has the possibility to sign or his representative if he is present * for hemorragic stroke : * age \> 18 year-old * hemorrhagic stroke diagnosed on clinical presentation and cerebral imaging (ct or mri imaging) * inclusion inferior to 6 hours from stroke onset * initial nihss score \> 0 at the time of clinical examination * hemorrhagic patients are paired for age and sex with ischemic patients * procedure of signed consent in situation of emergency : consent of the patient if he has the possibility to sign or his representative if he is present for healthy controls : * age \> 18 year-old * stroke-free standardized questionnaire * initial nihss score = 0 * rankin score = 0 * high risk cardiovascular subjects * controls are paired for age, sex and cardiovascular risk measured by a score (european heart score) with ischemic patients exclusion criteria: * not affiliated to social security * patient under legal protection or deprived of liberty by a judicial or administrative decision * patient whose follow-up will be impossible * prior stroke group for ischemic stroke : - patients with tia and a negative cerebral ct or mri group for hemorragic stroke : * cerebral hemorrhage related to subarachnoid hemorrhage * post-traumatic hemorrhage * hemorrhagic transformation in patients with ischemic stroke group for healthy controls : - contraindication mri